Akeso's Ivonescimab Shows 30.8-Month Median OS in First-Line PD-L1-Positive NSCLC

Data from a randomized, double-blind, controlled, multicenter registrational Phase III clinical study presented at the 2026 World Conference on Lung Cancer show that Akeso's PD-1/VEGF bispecific antibody ivonescimab was compared with pembrolizumab in the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression (PD-L1 TPS at least 1%). In the intent-to-treat population, median overall survival (OS) was 30.8 months in the ivonescimab arm, 8.2 months longer than in the pembrolizumab arm.

In the PD-L1 TPS at least 50% population, median OS was not yet reached in the ivonescimab arm, compared with 23.2 months in the pembrolizumab arm. The study is a registrational Phase III clinical trial of ivonescimab monotherapy compared head-to-head with pembrolizumab.

Pembrolizumab was developed by Merck. In the 2024 ranking of globally best-selling drugs, pembrolizumab ranked first, with global sales of USD 29.482 billion; in 2025, its global sales were USD 31.68 billion, remaining the highest-selling drug in the global oncology field. Pembrolizumab's earlier efficacy in first-line treatment of PD-L1-positive NSCLC helped make PD-1 monoclonal antibodies an important drug class in immunotherapy for solid tumors.

Xia Yu, founder and chairman of Akeso, said on a telephone conference held on September 13 that the Phase III clinical study of ivonescimab was launched at the end of 2022. The study chose to compare monotherapy with monotherapy against pembrolizumab in the PD-L1 TPS at least 1% population. Xia said that after 36 months of follow-up, ivonescimab extended survival benefit, with no new safety signals observed.

PD-(L)1 is one of the core targets in tumor immunotherapy. Ivonescimab is a PD-1/VEGF bispecific antibody that can exert both immune effects and anti-angiogenic effects. Multiple pharmaceutical companies worldwide are currently conducting research and development in the PD-1/VEGF bispecific antibody field. The data disclosed by Akeso come from a study in the Chinese population. An international multicenter Phase III clinical study of ivonescimab monotherapy versus pembrolizumab in first-line treatment of NSCLC with high PD-L1 expression (HARMONi-7/AK112-3007) is ongoing.